Sterile Operations Team Lead

CPL

WATERFORD

1. Project Planning / Co-Ordination: A. Together With The Sterile Technical Operations Manager, Actively Plan For Each Project And Manufacturing Activity To Ensure Visibility To All Team Members And Key Stakeholders To Deliver On Time In Full. B. Together With The Sterile Technical Operations Manager, Determine Detailed Tasks And Resources Required To Deliver Each Project Milestone; Identify Equipment, Materials And People Needed And Allocate Resources To Tasks – On A Monthly/weekly Basis And Daily Adjustments As Required. C. Provide Project Plan Information To Clarify Situations Before Deciding A Way Forward Taking All The Facts On Board. Gain Agreement From Stakeholders To Support Ideas Or Take Action That Supports Or Builds The Partnership; Using Sound Rationale To Explain Value Of Actions. 2. Compliance: A. To Ensure That All Work Carried Out Complies With The Required Standards Conforming To Company, Cgxp, Sops, Regulatory Regulations And Guidelines, Safety And Environmental Guidelines. B. Ensure High Quality Output – Vigilantly Watch Over Job Processes, Tasks And Work Products To Ensure Freedom From Errors, Omissions Or Defects. C. Initiate Action To Correct Quality/schedule Problem Or Notify Others Of Quality Issues As Appropriate. If A Procedure Does Not Exist, Devise One, (Through The Appropriate Channels); If A Process Needs Amending, Do So Through The Appropriate Channels. 3. Continuous Improvement: A. To Identify And Make Recommendations For Improvements As Part Of A Team Within Or Outside The Department In Order To Ensure Continuous Improvement. Highlight Opportunities For System Optimisation To Team Members. 4. Documentation. A. To Ensure All Batch Documentation Is Generated And Completed Correctly. B. To Coordinate The Preparation Of Batch Documentation In Support Of Engineering Activities, Process Simulations And Product Manufacture. C. To Ensure Manufacturing Logbooks Are Completed Correctly. 5. Leadership. A. Coaching / Mentoring - Support Members Of Team With Problem Solving And Skill Development To Aid Learning And Early Problem Resolution. B. Recruitment – Assist With Recruitment Of Team Members In Line With Resource Requirements And To Job Spec. To Perform Additional Team Tasks As Agreed To Support Effective Running Of The Business. Essential Requirements: Qualified To A Minimum Of Degree Level. At Least 5 Years’ Experience Working In A Sterile Fill Finish Environment. Project Management Skills.

1616 days ago